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510(k) K920139

GLEESON CLOT-BUSTER by Conmedcorp — Product Code GCI

K920139 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "GLEESON CLOT-BUSTER". The FDA issued a decision of Substantially Equivalent on April 15, 1992. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Conmedcorp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1992
Date Received
January 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by Conmedcorp

  • K101534 — CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (November 24, 2010)
  • K061021 — ENTAKE STANDARD AND SAFETY PEG SYSTEM (April 28, 2006)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K050777 — PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 (April 22, 2005)
  • K050304 — FX WIRE ADVANCED MEASUREMENT GUIDEWIRE (March 8, 2005)
  • K041953 — VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART (August 9, 2004)
  • K021079 — ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX (July 1, 2002)
  • K021299 — CONMED HEATWAVE HAND-CONTROLLED ELETRODE (June 26, 2002)
  • K020186 — CONMED SYSTEM 5000 ESU (April 12, 2002)
  • K020135 — CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF (April 12, 2002)

Other clearances for product code GCI

  • K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (August 15, 2002)
  • K003222 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (November 3, 2000)
  • K001362 — KARL STORZ 3D VIDEO SYSTEM (July 17, 2000)
  • K933515 — BOOTY ENDOSCOPE WARMER (October 27, 1993)
  • K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (February 1, 1993)
  • K915762 — POOLE TIP SUCTION PROBE (March 13, 1992)
  • K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (October 30, 1991)
  • K911829 — ENDOSTAPLE (August 28, 1991)

FDA data resources